Randomized Clinical Trial Comparing Rehabilitation Robotic Versus Conventional After Breast Cancer Surgery

Not Applicable

• Conditions: Breast Cancer
• Interventions: Device: Armeo®Power; Other: Conventional rehabilitation protocol

• Registration Number: NCT04025112
• Lead Sponsor: Barretos Cancer Hospital

Brief Summary

The aim of this study is to evaluate the effects of rehabilitation robotics in upper limb functionality involved in the surgical treatment of breast cancer. The study will be conducted following the delineation of randomized clinical trial. It will be assessed 108 women aged between 30 and 60 years, submitted to surgical treatment of breast cancer and axillary dissection.

Detailed Description

Breast cancer is one of the most common neoplasia types, with greater involvement in the female population, showing a high mortality rate in Brazil, due to diagnosis in advanced stages. With the increased survival of women treated for breast cancer, the evaluation of the effect of therapeutic resources for the morbidities resulting from surgical treatment of breast cancer are essential. The aim of this study is to evaluate the effects of rehabilitation robotics in upper limb functionality involved in the surgical treatment of breast cancer. The study will be conducted following the delineation of randomized clinical trial. It will be assessed 108 women aged between 30 and 60 years submitted to surgical treatment of breast cancer and axillary dissection, divided between two equal groups: control group (GC) - composed of women who had undergone conventional rehabilitation and experimental group (GE) - composed of women who had undergone rehabilitation robotics. The data obtained in the study aim to improve the forms of intervention against the functional alterations resulting from surgical treatment.

Study Timeline

• Status Verified: 2019-04
• Study First Submitted: 2019-04-22
• Study First Submitted QC: 2019-07-17
• Last Update Submitted: 2019-07-17
• Study First Posted: 2019-07-18
• Last Update Posted: 2019-07-18
• Study Start: 2019-07-20
• Primary Completion: 2020-07-30
• Study Completion: 2020-12-20

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 108

Inclusion Criteria

• Women submitted to quadrantectomy, simple mastectomy, radical mastectomy or modified radical mastectomy with complete axillary dissection.
• Women from 30 to 60 years old.
• Postoperatory range from 20 to 80 days.

Exclusion Criteria

• Bilateral surgery
• Radiotherapy treatment in progress
• Upper limb metastasis

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Armeo	Armeo®Power	Patients group (54 patients) for robotic therapy.
Conventional	Conventional rehabilitation protocol	Patients group (54 patients) for conventional rehabilitation protocol.

Primary Outcome Measures

Name	Time	Method
Arm strength change	"15 days" and "30 days"	Arm strength measure will be performed with a hand dynamometer.
Change in the amplitude of arm movement	"15 days" and "30 days"	The amplitude of arm movement wil be measured by a goniometer.
Pain classification change	"15 days" and "30 days"	Pain measure will be done through Shoulder Pain and Disability Index (SPADI) questionnaire, classifying it from 0 (low) to 100 (high).
Upper limb disability change	"15 days" and "30 days"	This outcome wil be measured by Disability of the Arm, Shoulder and Hand (DASH) questionnaire, classifying it from 0 (low) to 100 (high).

Secondary Outcome Measures

Name	Time	Method
Quality of life change	"15 days" and "30 days"	Quality of life will be assessed by Functional Assessment of Cancer Therapy-Breast (FACT B+4) questionnaire.